[Recommendations of the S3 Guideline "Use of Extracorporeal Circulation (ECLS/ ECMO) for Cardiac and Circulatory Failure" of the Association of Scientific Medical Societies in Germany]. / Empfehlungen der S3-Leitlinie (AWMF) "Einsatz der extrakorporalen Zirkulation (ECLS/ECMO) bei Herz- und Kreislaufversagen".

In recent years, the use of mechanical support for patients with cardiac or circulatory failure has continuously increased, leading to 3,000 ECLS/ECMO (extracorporeal life support/extracorporeal membrane oxygenation) implantations annually in Germany. Due to the lack of guidelines, there is an urgent need for evidence-based recommendations addressing the central aspects of ECLS/ECMO therapy. In July 2015, the generation of a guideline level S3 according to the standards of the Association of the Scientific Medical Societies in Germany (AWMF) was announced by the German Society for Thoracic and Cardiovascular Surgery (GSTCVS). In a well-structured consensus process, involving experts from Germany, Austria and Switzerland, delegated by 16 scientific societies and the patients' representation, the guideline "Use of extracorporeal circulation (ECLS/ECMO) for cardiac and circulatory failure" was created under guidance of the GSTCVS, and published in February 2021. The guideline focuses on clinical aspects of initiation, continuation, weaning and aftercare, herein also addressing structural and economic issues. This article presents an overview on the methodology as well as the final recommendations.

[Use of extracorporeal circulation (ECLS/ECMO) for cardiac and circulatory failure : Short version of the S3 guideline]. / Einsatz der extrakorporalen Zirkulation (ECLS/ECMO) bei Herz- und Kreislaufversagen : Kurzversion der AWMF-S3-Leitlinie.

In Germany, a remarkable increase regarding the usage of extracorporeal membrane oxygenation (ECMO) and extracorporeal life support (ECLS) systems has been observed in recent years with approximately 3000 ECLS/ECMO implantations annually since 2015. Despite the widespread use of ECLS/ECMO, evidence-based recommendations or guidelines are still lacking regarding indications, contraindications, limitations and management of ECMO/ECLS patients. Therefore in 2015, the German Society of Thoracic and Cardiovascular Surgery (GSTCVS) registered the multidisciplinary S3 guideline "Use of extracorporeal circulation (ECLS/ECMO) for cardiac and circulatory failure" to develop evidence-based recommendations for ECMO/ECLS systems according to the requirements of the Association of the Scientific Medical Societies in Germany (AWMF). Although the clinical application of ECMO/ECLS represents the main focus, the presented guideline also addresses structural and economic issues. Experts from 17 German, Austrian and Swiss scientific societies and a patients' organization, guided by the GSTCVS, completed the project in February 2021. In this report, we present a summary of the methodological concept and tables displaying the recommendations for each chapter of the guideline.

[Use of extracorporeal circulation (ECLS/ECMO) for cardiac and circulatory failure : Short version of the S3 guideline]. / Einsatz der extrakorporalen Zirkulation (ECLS/ECMO) bei Herz- und Kreislaufversagen : Kurzversion der AWMF-S3-Leitlinie.

In Germany, a remarkable increase regarding the usage of extracorporeal membrane oxygenation (ECMO) and extracorporeal life support (ECLS) systems has been observed in recent years with approximately 3000 ECLS/ECMO implantations annually since 2015. Despite the widespread use of ECLS/ECMO, evidence-based recommendations or guidelines are still lacking regarding indications, contraindications, limitations and management of ECMO/ECLS patients. Therefore in 2015, the German Society of Thoracic and Cardiovascular Surgery (GSTCVS) registered the multidisciplinary S3 guideline "Use of extracorporeal circulation (ECLS/ECMO) for cardiac and circulatory failure" to develop evidence-based recommendations for ECMO/ECLS systems according to the requirements of the Association of the Scientific Medical Societies in Germany (AWMF). Although the clinical application of ECMO/ECLS represents the main focus, the presented guideline also addresses structural and economic issues. Experts from 17 German, Austrian and Swiss scientific societies and a patients' organization, guided by the GSTCVS, completed the project in February 2021. In this report, we present a summary of the methodological concept and tables displaying the recommendations for each chapter of the guideline.

[Acute right heart failure on the intensive care unit : Pathophysiology, monitoring and management]. / Akutes Rechtsherzversagen auf der Intensivstation : Pathophysiologie, Monitoring, Therapie.

Right ventricular heart failure is a frequent and serious but often undetected and complex clinical challenge on the intensive care unit. The commonest causes include acute decompensation of pulmonary hypertension, pulmonary embolism, sepsis, acute respiratory distress, and cardiothoracic surgery. The gold standard of bedside diagnosis is a combination of clinical symptoms, biochemical markers (NT-proBNP) and echocardiography. For the purposes of hemodynamic monitoring and treatment management, the indication to place a pulmonary artery catheter should be made generously. The major components of management include treating the underlying disease and triggering factors, reducing pulmonary vascular resistance, increasing contractility, volume optimization, and maintenance of adequate perfusion. Mechanical circulatory support should be considered before irreversible end-organ failure develops.

Prevalence, Diagnosis, Perioperative Monitoring and Treatment of Right Ventricular Dysfunction and/or Pulmonary Arterial Hypertension in Cardiac Surgical Patients in Germany-A Postal Survey.

Background Sparse data are available on the prevalence of right ventricular dysfunction and/or pulmonary arterial hypertension in patients scheduled for cardiac surgery in Germany as well as on the intensity and modalities used for diagnosis, perioperative monitoring, and treatment of these comorbidities. Methods A postal survey including questions on the prevalence of preoperative right ventricular dysfunction and/or pulmonary arterial hypertension in patients undergoing cardiac surgery in 2009 was sent to 81 German heart centers. Total 47 of 81 (58%) heart centers returned the questionnaires. The centers reported data on 51,095 patients, and 49.8% of the procedures were isolated coronary artery bypass grafting. Results Data on the prevalence of preoperative pulmonary hypertension and/or right ventricular dysfunction were not available in 54% and 64.6% of centers. In the remaining hospitals, 19.5% of patients presented right heart dysfunction and 10% pulmonary arterial hypertension. Preoperative echocardiography was performed in only 45.3% of the coronary artery bypass grafting cases. Preoperative pharmacologic treatment of pulmonary hypertension or right ventricular dysfunction with oral sildenafil, inhaled prostanoids, or nitric oxide was initiated in 71% and 95.7% of the centers, respectively. Intra- and postoperative treatment was most frequently accomplished with phosphodiesterase-III inhibitors. Conclusion The prevalence of preoperative right heart dysfunction and pulmonary arterial hypertension in cardiac surgical patients in Germany seems to be substantial. However, in more than 50% of the patients, no preoperative data on right ventricular function and pulmonary arterial pressure are available. This may lead to underestimation of perioperative risk and inappropriate management of this high-risk population.

Preoperative intra-aortic counterpulsation in high-risk patients undergoing cardiac surgery: a meta-analysis of randomized controlled trials†.

In contrast to the results of previous studies, recent randomized controlled trials (RCTs) failed to show a benefit of prophylactic aortic counterpulsation in high-risk patients undergoing cardiac surgery. The present analysis aims to redefine the effects of this treatment modality in the light of this new evidence. MEDLINE, EMBASE, CENTRAL/CCTR, Google Scholar and reference lists of relevant articles were searched for full-text articles of RCTs in English or German. Assessments for eligibility, relevance, study validity and data extraction were performed by two reviewers independently using prespecified criteria. The primary outcome was hospital mortality. A total of nine eligible RCTs with 1171 patients were identified: 577 patients were treated preoperatively with intra-aortic balloon pump (IABP) and 594 patients served as controls. The pooled odds ratio (OR) for hospital mortality (22 hospital deaths in the intervention arm, 54 in the control group) was 0.381 (95% CI 0.230-0.629; P < 0.001). The pooled analyses of five RCTs including only patients undergoing isolated on-pump coronary artery bypass grafting (n[IABP] = 348, n[control] = 347) also showed a statistically significant improvement in mortality for preoperative IABP implantation (fixed-effects model: OR 0.267, 95% CI 0.129-0.552, P < 0.001). The pooled OR for hospital mortality from two randomized off-pump trials was 0.556 (fixed-effects model, 95% CI 0.207-1.493, P = 0.226). Preoperative aortic counterpulsation was associated with a significant reduction in low cardiac output syndrome (LCOS) in the total population (fixed-effects model: OR 0.330, 95% CI 0.214-0.508, P < 0.001) as well as in the subgroup of CAGB patients (fixed-effects model: OR 0.113, 95% CI 0.056-0.226, P < 0.001), whereas there was no benefit in the off-pump population (fixed-effects model: OR 0.555, 95% CI 0.209-1.474, P = 0.238). Preoperative IABP implantation was associated with a reduction of intensive care unit (ICU) stay in all investigated populations with a greater effect in the total population [fixed-effects model: standard mean difference (SMD) -0.931 ± 0.198, P < 0.001] as well as in the subgroup of CAGB patients (fixed-effects model: SMD -1.240 ± 0.156, P < 0.001), compared with the off-pump group (fixed-effects model: SMD -0.723 ± 0.128, P < 0.001). Despite contradictory results from recent trials, the present study confirms the findings of previous meta-analyses that prophylactic aortic counterpulsation reduces hospital mortality, incidence of LCOS and ICU requirement in high-risk patients undergoing on-pump cardiac surgery. However, owing to small sample sizes and the lack of a clear-cut definition of high-risk patients, an adequately powered, prospective RCT is necessary to find a definite answer to the question, if certain groups of patients undergoing cardiac surgery benefit from a prophylactic IABP insertion.

[S3-Guideline: Recommendations for intra-aortic balloon pumping in cardiac surgery]. / S3-Leitlinie "Einsatz der intraaortalen Ballongegenpulsation in der Herzchirurgie".

Although intra-aortic balloon pumping (IABP) is the most frequently used mechanical cardiac assist device in cardiothoracic surgery, there are only guidelines for substantive sections of aortic counterpulsation including prophylactic and postoperative use. In contrast, evidence-based recommendations are still lacking concerning intraoperative use, management, contraindication and other relevant issues. According to international surveys, important aspects of IABP usage show a wide variation in clinical practice. The results of a national questionnaire performed before initiation of this guideline confirmed these findings and demonstrated a clear need for the development of a consensus-based guideline. Therefore, the presented multidisciplinary S-3-guideline was developed under the direction of the German Society for Thoracic and Cardiovascular Surgery (Deutsche Gesellschaft für Thorax-, Herz- und Gefäßchirurgie, DGTHG) to make evidence-based recommendations for the usage of aortic counterpulsation after cardiothoracic surgery according to the requirements of the Association of the Scientific Medical Societies in Germany (AWMF) and the Medical Centre for Quality (Ärztliches Zentrum für Qualität - (ÄZQ)). Main topics discussed in this guideline involve IABP support in the prophylactic, preoperative, intraoperative and postoperative setting as well as the treatment of right heart failure, contraindications, anticoagulation, monitoring, weaning, and limitations of IABP therapy. The presented 15 key messages of the guideline were approved after two consensus meetings under moderation of the AWMF with participation of the German Society of Cardiology (DGK), German Society of Anaesthesiology and Intensive Care Medicine (DGAI), German Interdisciplinary Association for Intensive Care (DIVI) and the German Society for Cardiovascular Engineering (DGfK).

Predictors for long-term outcome and quality of life of patients after cardiac surgery with prolonged intensive care unit stay.

OBJECTIVES: This study investigated factors determining the long-term outcome and quality of life of patients with a prolonged intensive care unit (ICU) stay after cardiac surgery. DESIGN: A retrospective analysis was performed in 230 patients that had undergone cardiac surgery and suffered from a post-operative ICU stay of 7 or more days at our institution. Among 11 pre-, 13 intra-, and 14 post-operative variables, factors influencing 5-year outcome were identified by logistic regression analysis. Quality of life was determined using the Short Form-36 questionnaire. RESULTS: In-hospital mortality was 12%. One hundred and eleven of 187 patients (59%) were alive after 5 years. Non-survivors were older (70 vs. 65 years, p = 0.005) and had a higher additive EuroSCORE (7 vs. 5, p = 0.034). Logistic regression identified pre-operative atrial fibrillation (AF), (28 vs. 10%, p = 0.003) as the strongest predictor for a 5-year outcome, followed by myocardial infarction (62 vs. 41%, p = 0.005), and prolonged mechanical ventilation (8 vs. 5 days, p = 0.036). Survivors did not show an impaired physical component summary SF-36 score (39 vs. 46, p = 0.737) or mental component summary score (55 vs. 55, p = 0.947) compared to an age-matched German Normative Sample. CONCLUSIONS: Pre-operative AF proved to be the most important factor determining the 5-year outcome of patients with a prolonged ICU stay after cardiac surgery. Neither physical nor mental health appeared to be impaired in these patients.

Postoperative neurocognitive dysfunction in patients undergoing cardiac surgery after remote ischemic preconditioning: a double-blind randomized controlled pilot study.

BACKGROUND: Remote ischemic preconditioning (RIPC) has been shown to enhance the tolerance of remote organs to cope with a subsequent ischemic event. We hypothesized that RIPC reduces postoperative neurocognitive dysfunction (POCD) in patients undergoing complex cardiac surgery. METHODS: We conducted a prospective, randomized, double-blind, controlled trial including 180 adult patients undergoing elective cardiac surgery with cardiopulmonary bypass. Patients were randomized either to RIPC or to control group. Primary endpoint was postoperative neurocognitive dysfunction 5-7 days after surgery assessed by a comprehensive test battery. Cognitive change was assumed if the preoperative to postoperative difference in 2 or more tasks assessing different cognitive domains exceeded more than one SD (1 SD criterion) or if the combined Z score was 1.96 or greater (Z score criterion). RESULTS: According to 1 SD criterion, 52% of control and 46% of RIPC patients had cognitive deterioration 5-7 days after surgery (p = 0.753). The summarized Z score showed a trend to more cognitive decline in the control group (2.16±5.30) compared to the RIPC group (1.14±4.02; p = 0.228). Three months after surgery, incidence and severity of neurocognitive dysfunction did not differ between control and RIPC. RIPC tended to decrease postoperative troponin T release at both 12 hours [0.60 (0.19-1.94) µg/L vs. 0.48 (0.07-1.84) µg/L] and 24 hours after surgery [0.36 (0.14-1.89) µg/L vs. 0.26 (0.07-0.90) µg/L]. CONCLUSIONS: We failed to demonstrate efficacy of a RIPC protocol with respect to incidence and severity of POCD and secondary outcome variables in patients undergoing a wide range of cardiac surgery. Therefore, definitive large-scale multicenter trials are needed. TRIAL REGISTRATION: ClinicalTrials.gov NCT00877305.

Automatic control of pressure support for ventilator weaning in surgical intensive care patients.

RATIONALE: Despite its ability to reduce overall ventilation time, protocol-guided weaning from mechanical ventilation is not routinely used in daily clinical practice. Clinical implementation of weaning protocols could be facilitated by integration of knowledge-based, closed-loop controlled protocols into respirators. OBJECTIVES: To determine whether automated weaning decreases overall ventilation time compared with weaning based on a standardized written protocol in an unselected surgical patient population. METHODS: In this prospective controlled trial patients ventilated for longer than 9 hours were randomly allocated to receive either weaning with automatic control of pressure support ventilation (automated-weaning group) or weaning based on a standardized written protocol (control group) using the same ventilation mode. The primary end point of the study was overall ventilation time. MEASUREMENTS AND MAIN RESULTS: Overall ventilation time (median [25th and 75th percentile]) did not significantly differ between the automated-weaning (31 [19-101] h; n = 150) and control groups (39 [20-118] h; n = 150; P = 0.178). Patients who underwent cardiac surgery (n = 132) exhibited significantly shorter overall ventilation times in the automated-weaning (24 [18-57] h) than in the control group (35 [20-93] h; P = 0.035). The automated-weaning group exhibited shorter ventilation times until the first spontaneous breathing trial (1 [0-15] vs. 9 [1-51] h; P = 0.001) and a trend toward fewer tracheostomies (17 vs. 28; P = 0.075). CONCLUSIONS: Overall ventilation times did not significantly differ between weaning using automatic control of pressure support ventilation and weaning based on a standardized written protocol. Patients after cardiac surgery may benefit from automated weaning. Implementation of additional control variables besides the level of pressure support may further improve automated-weaning systems. Clinical trial registered with www.clinicaltrials.gov (NCT 00445289).